Symptomatic Irreversible PulpitisNCT07859267
Effect of Preoperative Video-Guided Breathing on Pain in Symptomatic Irreversible Pulpitis
A study testing Video-Guided Breathing Exercise in people with Symptomatic Irreversible Pulpitis and Postoperative Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized controlled clinical trial is to evaluate whether a brief preoperative video-guided breathing exercise reduces postoperative pain in adults undergoing single-visit root canal treatment for symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis, Postoperative Pain
- What is being tested?
- Video-Guided Breathing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2026to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Presence of preoperative pain in the tooth to be treated
- Diagnosis of symptomatic irreversible pulpitis
- Positive response to thermal and electric pulp sensitivity tests
- No periapical radiolucent lesion on periapical radiography
Show all 9Show fewer
- Indication for primary root canal treatment
- Root canal treatment planned to be completed in a single visit
- Only one tooth included per participant
Who cannot join
- Previous root canal treatment in the tooth to be treated
- Presence of acute apical abscess
- Presence of a periapical radiolucent lesion
- Pulp necrosis
- Use of analgesic medication within 24 hours before treatment
- ASA physical status III or higher
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Two-Minute Preoperative Video-Guided Breathing Exercise on Intraoperative and Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Clinical Trial
The goal of this randomized controlled clinical trial is to evaluate whether a brief preoperative video-guided breathing exercise reduces postoperative pain in adults undergoing single-visit root canal treatment for symptomatic irreversible pulpitis.
The main questions it aims to answer are:
Read more
- Does a 2-minute video-guided breathing exercise reduce postoperative pain 24 hours after root canal treatment compared with a 2-minute period of passive rest?
- Does the breathing exercise affect pain experienced during root canal treatment or postoperative pain at 6, 12, 48, and 72 hours?
- Does the breathing exercise reduce the need for supplemental local anesthesia during treatment?
- Does the breathing exercise reduce analgesic use during the first 72 hours after treatment?
- Does the breathing exercise produce a greater immediate change in heart rate compared with passive rest?
Participants will be randomly assigned to one of two groups before root canal treatment.
In the video-guided breathing exercise group, participants will watch a standardized 2-minute video and follow a controlled breathing pattern consisting of inhaling through the nose for 4 seconds followed by exhaling for 6 seconds. This breathing cycle will be repeated throughout the video.
In the passive rest group, participants will remain seated in the dental chair for 2 minutes without receiving any breathing or relaxation instructions and will be asked to breathe normally.
All participants will then receive single-visit root canal treatment using the same standardized endodontic treatment protocol.
Postoperative pain will be assessed at 6, 12, 24, 48, and 72 hours after treatment. Pain at 24 hours will be the primary outcome. Maximum pain experienced during treatment, supplemental anesthesia requirement, analgesic use during the first 72 hours, and change in heart rate immediately before and after the assigned preoperative intervention will also be evaluated.
- Being tested
- Video-Guided Breathing Exercise
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Guided Breathing ExerciseBehavioural
Participants assigned to the intervention group will perform a standardized 2-minute video-guided breathing exercise immediately before root canal treatment. During the exercise, participants will be instructed to inhale through the nose for 4 seconds and then exhale for 6 seconds. This breathing cycle will be repeated throughout the 2-minute video. The same video will be used for all participants to standardize the instructions and duration of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Video-Guided Breathing Exercise | Experimental | Participants will perform a standardized 2-minute video-guided breathing exercise before root canal treatment. They will be instructed to inhale through the nose for 4 seconds and then exhale for 6 seconds, repeating this breathing cycle throughout the video. Receives: Behavioral: Video-Guided Breathing Exercise |
| Passive Rest | No intervention | Participants will remain seated in the dental chair for 2 minutes before root canal treatment without receiving any breathing or relaxation instructions. They will be asked to continue breathing naturally during this period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain at 24 Hours
Postoperative pain intensity will be assessed 24 hours after single-visit root canal treatment using a 10-cm visual analog scale (VAS), with 0 representing "no pain" and 10 representing "the worst imaginable pain."
Measured: 24 hours after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start9 May 2026
- Primary completion10 Sep 2026
- Study completion25 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Gürler, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859267
- Sponsor's protocol ID
- 08.05.2026/166
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verma MR, Rao RD, Langade D, Jain AK, Guha A, Mohan M. Assessment of yogic relaxation techniques for its anxiolytic effects in patients requiring endodontic treatment: A prospective, randomized controlled study. J Conserv Dent. 2021 Mar-Apr;24(2):209-213. doi: 10.4103/jcd.jcd_97_21. Epub 2021 Oct 9.
PubMed 34759592
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Two-Minute Preoperative Video-Guided Breathing Exercise on Intraoperative and Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07859267
- Acronym / sponsor ID
- 08.05.2026/166
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 9 May 2026 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 25 Sep 2026 (actual)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled clinical trial is to evaluate whether a brief preoperative video-guided breathing exercise reduces postoperative pain in adults undergoing single-visit root canal treatment for symptomatic irreversible pulpitis.
The main questions it aims to answer are:
- Does a 2-minute video-guided breathing exercise reduce postoperative pain 24 hours after root canal treatment compared with a 2-minute period of passive rest?
- Does the breathing exercise affect pain experienced during root canal treatment or postoperative pain at 6, 12, 48, and 72 hours?
- Does the breathing exercise reduce the need for supplemental local anesthesia during treatment?
- Does the breathing exercise reduce analgesic use during the first 72 hours after treatment?
- Does the breathing exercise produce a greater immediate change in heart rate compared with passive rest?
Participants will be randomly assigned to one of two groups before root canal treatment.
In the video-guided breathing exercise group, participants will watch a standardized 2-minute video and follow a controlled breathing pattern consisting of inhaling through the nose for 4 seconds followed by exhaling for 6 seconds. This breathing cycle will be repeated throughout the video.
In the passive rest group, participants will remain seated in the dental chair for 2 minutes without receiving any breathing or relaxation instructions and will be asked to breathe normally.
All participants will then receive single-visit root canal treatment using the same standardized endodontic treatment protocol.
Postoperative pain will be assessed at 6, 12, 24, 48, and 72 hours after treatment. Pain at 24 hours will be the primary outcome. Maximum pain experienced during treatment, supplemental anesthesia requirement, analgesic use during the first 72 hours, and change in heart rate immediately before and after the assigned preoperative intervention will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-Guided Breathing Exercise | Experimental | Behavioral: Video-Guided Breathing ExerciseParticipants will perform a standardized 2-minute video-guided breathing exercise before root canal treatment. They will be instructed to inhale through the nose for 4 seconds and then exhale for 6 seconds, repeating this breathing cycle throughout the video. |
| Passive Rest | No intervention | –Participants will remain seated in the dental chair for 2 minutes before root canal treatment without receiving any breathing or relaxation instructions. They will be asked to continue breathing naturally during this period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Presence of preoperative pain in the tooth to be treated
- Diagnosis of symptomatic irreversible pulpitis
- Positive response to thermal and electric pulp sensitivity tests
Key exclusion criteria (7 listed)
- Previous root canal treatment in the tooth to be treated
- Presence of acute apical abscess
- Presence of a periapical radiolucent lesion
- Pulp necrosis
- Use of analgesic medication within 24 hours before treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-Guided Breathing ExerciseParticipants assigned to the intervention group will perform a standardized 2-minute video-guided breathing exercise immediately before root canal treatment. During the exercise, participants will be instructed to inhale through the nose for 4 seconds and then exhale for 6 seconds. This breathing cycle will be repeated throughout the 2-minute video. The same video will be used for all participants to standardize the instructions and duration of the intervention. | Behavioural | Video-Guided Breathing Exercise |
Primary outcome
Postoperative Pain at 24 Hours
Time frame: 24 hours after root canal treatment
Postoperative pain intensity will be assessed 24 hours after single-visit root canal treatment using a 10-cm visual analog scale (VAS), with 0 representing "no pain" and 10 representing "the worst imaginable pain."
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 34759592Verma MR, Rao RD, Langade D, Jain AK, Guha A, Mohan M. Assessment of yogic relaxation techniques for its anxiolytic effects in patients requiring endodontic treatment: A prospective, randomized controlled study. J Conserv Dent. 2021 Mar-Apr;24(2):209-213. doi: 10.4103/jcd.jcd_97_21. Epub 2021 Oct 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-Guided Breathing Exercise in people with Symptomatic Irreversible Pulpitis and Postoperative Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain at 24 Hours (time frame: 24 hours after root canal treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07859267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.